FDA.reportPublic FDA data

MAUDE MDR 9834913

MDR report key
9834913
Report number
MW5093768
Event key
0
Event type
3
Date of event
2020-03-08
Date received
2020-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANTI BACTERIA, POLLUTION AND DUST MASK N95RESPIRATOR, SURGICALUNKMSHI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-130

Event Narratives#

D

Patient 1

ORDERED AND RECEIVED A SO CALLED N 95 MASK FROM COMPANY STABILITY PRO - (B)(4) BASED. THE PRODUCT CAME IN A CELLOPHANE BAG WITHOUT ANY LABEL, PRECAUTIONS, INSTRUCTIONS FOR USE OR OTHER INFO REGARDING PRODUCT OR MATERIALS ETC. MASK IS CLEARLY A COUNTERFEIT. MADE OF NEOPRENE, FUMES ENOUGH TO CAUSE COUGH. ONE PAPER MASK LINER AND SIDE FILTERS HOLDERS WITHOUT FILTERS. ADVERTISED PRODUCT SAID WOULD COME WITH FILTERS. COST WAS (B)(6). THEY DO NOT RESPOND TO EMAIL. NO TESTING. WAS NOT MADE AVAILABLE. FDA SAFETY REPORT ID# (B)(4).